Study of Cytokine Removal During Surgery in Critically Ill Adults With Infective Endocarditis Comparing Two Treatment Protocols

What this Trial Is About

Researchers are studying patients with infectious endocarditis IE and other severe infections that can cause major changes in the immune system, including a reduced immune function called injury-associated immunosuppression IAI. This condition is linked to longer intensive care stays, more infections, and higher risk of death. The study aims to compare two established treatment protocols to see if using a cytokine adsorption filter during surgery can improve immune response in these seriously ill patients. The trial involves two treatment groups one receiving the standard cardiac surgery protocol without adsorption, and the other receiving surgery with cytokine adsorption during the operation via an extracorporeal circuit. Both groups receive antibiotic therapy for up to 14 days before surgery. The adsorption treatment is studied as an additional step to potentially increase immune competence in patients undergoing surgical therapy for IE. Participants will be closely monitored before, during, and after surgery with assessments including immune cell markers mHLA-DR expression, inflammatory markers like cytokines, organ function scores, length of ICU and hospital stay, and various therapy usage measures. Outcomes such as mortality rates and duration of supportive therapies will be tracked up to 90 days after ICU admission. The study uses random assignment to the two treatment protocols and involves regular blood tests and clinical evaluations to measure immune and organ function changes.

Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)